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TRaC has received full accreditation at its UK facilities to
carry out safety testing of all medical diagnostic products that fall
within the scope of the EU In Vitro Diagnostic (IVD) Medical Devices
Directive.

In vitro devices are items of diagnostic equipment that carry out
medical tests on samples (for example, blood) obtained from the
human body, but that do not operate directly in contact with the
body. The IVD Directive lays down a specific set of requirements for
such equipment (distinct from diagnostic equipment such as monitors
that are connected to the patient and have their own regulatory
framework) in terms of their safety, quality and performance.

The IVD Directive sets out four classifications of product:
General; Self-Test (ie products that patients may use themselves
without medical supervision); and two higher categories of Test
Kits; and Devices that test for specified conditions.

As with any electrical product offered for sale in Europe, the
supplier within the EU must affix the CE Mark; specified test
regimes range from Self-Declaration of Conformance by the
manufacturer (which is permitted for the General product category);
through to a Declaration endorsed via an audit by a Notified Body;
to a full third-party test programme carried out on production
samples of a product.

TRaC is authorised and equipped to review design dossiers that
manufacturers prepare, and to carry out type-testing where
appropriate, in respect of the Safety requirements of the Directive.

TRaC is accredited by UKAS (United Kingdom Accreditation Service)
for EN 61010-2-101, the standard that governs safety in laboratory
equipment, and especially (IVD) medical equipment. This
qualification increases TRaC’s support of Medical Device
manufacturers by adding the endorsement of a widely-recognised test
house to the CE Marking of their products, and by speeding their
time-to-market through comprehensive knowledge of the IVD
Directive’s regulations and processes.

As with the many other Standards and Directives for which the
test house holds qualifications, TRaC’s involvement with a client’s
product design cycle can begin long before the audit or test
programme is due, ensuring that all requirements are met during the
design process and avoiding any delays as the product comes to
market.

TRaC provides accredited approval services for other legislative
requirements applicable to these products and through close
coordination can manage complete qualification and approval
programmes.